Gardasil A Prime Suspect in Two DeathsJan 25, 2008 | Parker Waichman LLP
Gardasil has been linked to the deaths of two women in Europe, prompting more concerns about the controversial cervical cancer vaccine. In the U.S., the Food and Drug Administration (FDA) approved Gardasil in 2006 to prevent against four Human Papilloma Virus (HPV) strains which are responsible for 70 percent of all cervical cancer cases. The European Medicines Agency (EMEA) said one of the young women who received Gardasil died in Germany, the other in Austria. No ages have been released.
This week’s deaths follow the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered, with 1,700 other patients suffering adverse reactions.
Gardasil has been hailed as a breakthrough by the United Kingdom’s (UK) Department of Health, which backs an annual vaccination program, effective September, for girls aged 11 to 13 years. The department claims the policy will reduce yearly cervical cancer deaths by 1,000.
An EMEA spokesman said 1.5 million people had received the vaccine in Europe and there are no plans to change advice on the use of the vaccine. Gardasil, made by Merck, is one of the injections to be used initially. The other is Cervarix, made by Glaxo-SmithKline. Dr Nicholas Kitchin, medical director at Sanofi Pasteur MSD, which markets Gardasil, said, "The authorities in the two countries have looked intensively at these two cases and have not established a causal link, and this has been endorsed by the EMEA. The fact that the EMEA is not taking any action on the back of this should be seen as reassuring that the product remains safe."
Some feel mandating Gardasil would protect all women. Others oppose a vaccine that prevents a sexually transmitted infection, believing usurps parental authority, while some religious groups believe it could lead to promiscuity. Gardasil has been recommended for young girls because they are the least likely to have been exposed to HPV, making the vaccine—in theory—more effective. FDA estimates indicate that by the time they reach age 50, about 80% of all women have been exposed to one or more strains of HPV.
Shortly after its approval, a Centers for Disease Control (CDC) Advisory Panel voted unanimously to recommend all girls between 11 and 12 receive the vaccine, concluding Gardasil appeared to have no side effects other than injection site soreness. This recommendation, along with intense lobbying by Merck, caused 20 states to push for federal mandates to make Gardasil mandatory for sixth grade girls; N.Y. was not among them. Emerging research suggests the CDC erred. FDA documents indicate Gardasil may be responsible for at least eight deaths. Since its approval, there had been 3,461 complaints of adverse reactions to Gardasil. In several instances, blood clots were reported following injection; other side effects include paralysis, Bells Palsy, Guillain-Barre Syndrome. Of 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities. Despite this, Merck is marketing Gardasil as being nearly side effect free.